Norethindrone Pregnancy Warnings

Animal reproduction studies have not been conducted with this drug. There are no controlled data from human pregnancy studies. Use during the first trimester of pregnancy may be associated with congenital malformations in male and female fetuses and virilization of the external genitalia of the female fetus.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

AU TGA pregnancy category: DUS FDA pregnancy category: X

Comments:-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.-Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):